Sr. Device Engineer
Pfizer Statistics Program
Summary
This role has primary responsibility for confirmation that medical devices and drug/device combination products meet their intended function. This includes development of data through engineering studies that informs new product development as well as test reports that support product submissions. The candidate will work within a team environment to solve problems and utilize best engineering practices and techniques for root cause and statistical analysis. This work entails defining test methods, developing protocols, performing data analysis, and writing reports in compliance with corporate procedures.
Job description
Use Your Power for Purpose
This role has primary responsibility for confirmation that medical devices and drug/device combination products meet their intended function. This includes development of data through engineering studies that informs new product development as well as test reports that support product submissions. The candidate will work within a team environment to solve problems and utilize best engineering practices and techniques for root cause and statistical analysis. This work entails defining test methods, developing protocols, performing data analysis, and writing reports in compliance with corporate procedures.
What You Will Achieve
- Partner with Systems engineers in defining product requirements such that they are verifiable
- Development of test fixtures, test methods, and performance of Test Method Validation activities
- Coordinate with internal and external partners and suppliers to procure test samples and manage conditioning and accelerated aging studies
- Ensure integrity and compliance of data according to Standard Operating Procedures
- Develop Verification Plans including test strategy
- Utilize technical writing and statistical data analysis skills to write protocols and reports
- As necessary, conduct root cause analysis and derive recommendations based on analysis of data
- Translate inspections and tests methods into component and product specifications
- Potential for Project Team lead responsibilities including MS Project schedule creation/maintenance, device team meetings, and overall team management
Here Is What You Need (Minimum Requirements)
- Applicant must have a bachelor's degree with at least 2 years of experience; OR a master's degree with 0+ years of experience; OR an associate's degree with 6 years of experience; OR a high school diploma (or equivalent) and 8 years of relevant experience
Bonus Points If You Have (Preferred Requirements)
- Experience in the pharmaceutical or biotechnology industry
- Familiarity with Good Manufacturing Practices (GMP)
- Experience with statistical software (e.g., Minitab, JMP)
- Ability to lead cross-functional teams
- Strong organizational skills
- Adaptability and flexibility in a dynamic work environment
- Ability to mentor and develop junior team members
- Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and enhance productivity. Demonstrated curiosity for exploring how these tools can improve outcomes and understanding of responsible AI practices, including risk management and ethical use
Requirements
- Bachelor's degree with at least 2 years of experience; OR master's degree with 0+ years of experience; OR associate's degree with 6 years of experience; OR high school diploma (or equivalent) and 8 years of relevant experience
- Experience in the pharmaceutical or biotechnology industry
- Familiarity with Good Manufacturing Practices (GMP)
- Experience with statistical software (e.g., Minitab, JMP)
- Ability to lead cross-functional teams
- Strong organizational skills
- Adaptability and flexibility in a dynamic work environment
- Ability to mentor and develop junior team members
- Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot
Benefits
- 401(k) Matching
- Retirement Savings Contribution
- Paid Vacation
- Paid Holidays
- Personal Days
- Paid Caregiver Leave
- Paid Parental Leave
- Paid Medical Leave
- Medical Insurance
- Prescription Drug Coverage
- Dental Insurance
- Vision Coverage
Company overview
The Pfizer Statistics Program represents the statistical and data sciences functions within Pfizer Inc., one of the world's premier biopharmaceutical companies. This specialized program encompasses both the statistical analysis capabilities that support Pfizer's drug development pipeline and the educational initiatives like the Breakthrough Fellowship Program that includes MS Statistics components. As part of Pfizer's Research & Development organization, the Statistics Program plays a critical role in clinical trial design, data analysis, regulatory submissions, and evidence generation for Pfizer's innovative medicines and vaccines. The program employs advanced statistical methodologies and data science techniques to ensure the scientific rigor and integrity of Pfizer's clinical research across therapeutic areas including oncology, internal medicine, immunology, and vaccines. Through its integration with Pfizer's global operations, the Statistics Program contributes to the company's mission of delivering breakthroughs that change patients' lives by providing robust statistical support from early discovery through post-marketing surveillance.